09/10/2007 - 09:12

pSivida opens enrolments for macular edema treatment trials

09/10/2007 - 09:12

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Perth-based biotechnology company pSivida Ltd has completed enrolment for the first studies of absorption, distribution and metabolism of its diabetic macular edema treatment Medidur, the company has announced.


Perth-based biotechnology company pSivida Ltd has completed enrolment for the first studies of absorption, distribution and metabolism of its diabetic macular edema treatment Medidur, the company has announced.

 

 

The full text of a company announcement is pasted below

ATLANTA, October 8, 2007 - Alimera Sciences Inc., a privately held ophthalmic pharmaceutical company, and pSivida Limited (NASDAQ:PSDV, ASX:PSD, Xetra:PSI), announced today that enrollment is complete for the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study of Medidur™ FA for the treatment of Diabetic Macular Edema. FAME is a double masked, randomized, multi-center study that is following over 900 patients in the U.S., Canada, Europe, and India, for 36 months with safety and efficacy assessed at two years. Alimera Sciences and pSivida are jointly developing Medidur FA under a collaborative research and development agreement.

"Alimera Sciences is very excited to have completed enrollment in the FAME Study as this brings us closer to taking Medidur FA, the next generation of retinal drug delivery, to market and to our ultimate goal of delivering treatments that enrich patients' quality of life," said Alimera CEO Dan Myers.

Medidur, a tiny, injectable insert, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME). Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.

"This marks an important milestone for the Company in our profit sharing collaboration with Alimera. We are very pleased at the continued development of Medidur FA, based on our technologies that have already been approved for two back of the eye diseases.

We are optimistic that Medidur FA will offer a solution to the large market we see for this product," said pSivida Limited Managing Director, Dr Paul Ashton.

Diabetic retinopathy (DR), a complication of diabetes mellitus, is the leading cause of blindness in the working-age population of developed countries. At any time during progression of diabetic retinopathy, patients can develop DME which involves retinal thickening of the macular area. More than 500,000 people live with DME in the United States and this number is expected to exceed 700,000 by the year 2010. Currently there are no FDA approved drug treatments for DME.

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